Pacifiers must meet safety and labeling rules, including limits on toxic substances, N-nitrosamines, and hazardous parts, and advertising or written material must not misstate the law or suggest noncompliant use or modification.
Pacifiers Regulations His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 37 of the Canada Consumer Product Safety Acta, makes the annexed Pacifiers Regulations. S.C. 2010, c. 21 Definition of pacifier In these Regulations, pacifier means a pacifier that has a nipple and includes a similar product that is intended for use in a baby’s mouth. Toxic substance Any pacifier that contains a toxic substance must comply with section 25 of the Toys Regulations in relation to that substance. Limit of volatile N-nitrosamines A pacifier must not contain more than 10 µg/kg total volatile N-nitrosamines, as determined by dichloromethane extraction. Hazards A pacifier must be free from any part that may cause, under reasonably foreseeable conditions of use, injury to the user due to the following hazards: obstruction of the pharyngeal orifice; strangulation; ingestion or aspiration of the pacifier or any of its parts; and wounding. Additional requirements A pacifier must meet the following requirements: the nipple must be attached to a guard of such dimensions that it cannot pass through the opening in the template illustrated in Schedule 1 when the nipple is centered on the opening and a force of 9.8 N is applied axially to the nipple in such a way as to induce the guard to pull through the opening in the template; when tested in accordance with Schedule 2, the nipple must remain attached to the guard, and any part that separates from the pacifier must not, in a non-compressed state, fit entirely into the small parts cylinder illustrated in Schedule 3; any loop of cord or other material that is attached to the pacifier must not be more than 356 mm in circumference; and any ring or handle must be hinged, collapsible or flexible. Reference to Canada Consumer Product Safety Act or Regulations Written information that appears on a pacifier, that accompanies one or that is in any advertisement for one must not make any direct or indirect reference to the Canada Consumer Product Safety Act or these Regulations. Representations — use or modification Any written information that appears on or that accompanies a pacifier, and any advertisement of one, must not make representations in respect of the use of or modification to the pacifier that would result in the failure of the pacifier to meet a requirement of these Regulations. [Repeal] Registration These Regulations come into force on the day on which they are registered. The following method is to be used for testing the structural integrity of the pacifier: hold the nipple of the pacifier in a fixed position and apply to the ring or handle of the pacifier a force of 44.5 ± 1.0 N in the plane of the axis of the nipple at a rate of 4.5 ± 1.0 N/s and then maintain the final force for 10 ± 0.5 s; hold the guard of the pacifier in a fixed position and apply to the ring or handle of the pacifier a force of 44.5 ± 1.0 N in the plane perpendicular to the axis of the nipple at a rate of 4.5 ± 1.0 N/s and then maintain the final force for 10 ± 0.5 s; repeat the procedure described in paragraph (b) with the force applied to the nipple of the pacifier; immerse the pacifier in boiling water for 10 ± 0.5 min, then remove the pacifier from the boiling water and allow to cool in air at 21 ± 5° C for 15 ± 0.5 min; repeat the procedures described in paragraphs (a) to (c); and repeat the procedures described in paragraphs (d) and (e) nine times.